What are Clinical Trials?

A clinical study is a type of medical research that involves people. In this article, we use the term clinical study to refer to research studies that test new treatments, medications, or medical devices – often called as clinical trials.

A clinical study is carefully planned and carried out to evaluate how safe and effective a treatment is, and to look at possible side effects. Clinical studies are an essential step in developing and improving treatments, and in building medical knowledge.

Clinical studies play a critical role in advancing medical science, helping to bring new and improved treatments to patients. Results from clinical studies are used by regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) when deciding whether a treatment can be approved and marketed.

Did you know?
Every prescription medicine available today has gone through several phases of clinical studies before it was approved.

Key components of clinical studies

Study Phases

Phase 1: Tests safety and dosage of a new treatment in a small group of healthy volunteers.
Phase 2: Involves more participants, usually patients with the condition, to further test safety and early signs of effectiveness.
Phase 3: Includes a large and more diverse group, to confirm effectiveness, monitor side effects, and compare the treatment to standard care or placebo.
Phase 4: Conducted after approval, to monitor long-term safety and effectiveness in the wider population.

Did you know?
In a randomized clinical study, neither the patient nor sometimes even the doctor knows who is getting the real treatment or a placebo – this helps keep the results fair and unbiased.

Randomization and Blinding

Randomization: Participants are randomly placed into groups (for example, treatment group or control group) to avoid bias.
Blinding (or masking): Participants – and sometimes researchers – do not know which group they are in, to reduce bias.

Control Groups

In many clinical studies, there is a control group that receives either a standard treatment or a placebo (an inactive substance). This helps researchers compare the effects of the new treatment to existing ones or to no treatment.

Did you know?
Before joining a clinical study, participants must give informed consent. This means they receive clear information about the study and their right to leave at any time.

Informed Consent

Participants must provide informed consent before joining a clinical study. This involves receiving detailed information about the study’s purpose, procedures, potential risks and benefits, and the right to withdraw at any time.

Ethical Considerations

All studies must follow ethical guidelines to protect participants’ rights and well-being. Study plans are reviewed and approved by Ethics Committees or Institutional Review Boards (IRBs).

Endpoints and Outcomes

Studies define specific goals (endpoints) to measure if a treatment works. These can include improved symptoms, longer survival, or other health indicators.

Data Collection and Analysis

Data is collected carefully and analyzed to show whether the results are meaningful or could have happened by chance.

What is a clinical study?